Synthetic Biology is a dynamic field of research with an application-related focus to which contributions are made from disciplines that have a biological, technical and information processing emphasis. The main research fields and goals of Synthetic Biology have already been introduced by the German Central Committee on Biological Safety (ZKBS) (key word Synthetic Biology in the focus topics section).

The Federal Ministry of Food and Agriculture (BMEL) has commissioned the ZKBS to monitor developments in the field of Synthetic Biology in order to expertly and with a view to biosafety monitor current scientific developments in various fields of research. The monitoring aims to identify in good time whether existing regulations need to be adapted.

There is no specific regulation in Germany or Europe for risk assessment in Synthetic Biology. Because most research approaches in Synthetic Biology generate genetically modified organisms (GMOs), their potential risk can be assessed using existing methods. These can be found in the European Directives 2009/41/EC (System Directive, contained use) and 2001/18/EC (Deliberate Release Directive), which have been implemented in the German Genetic Engineering Act (GenTG). The ZKBS checks whether the current research projects are covered through the applicability of the GenTG.

The ZKBS published its first report on Synthetic Biology in Germany in 2012. The second ZKBS report appeared in 2018, summarizing the state of research in the various fields of Synthetic Biology worldwide.

The ZKBS has been conducting continuous monitoring of developments in the field of Synthetic Biology since June 2018. A selection of relevant publications is presented here and is updated regularly. Based on the continuous monitoring, the third report on synthetic biology was published in July 2022.

All three ZKBS reports (status December 2021) establish that all of the research areas in Synthetic Biology defined by the ZKBS are regulated by already existing legal specifications such as European directives and the GenTG and currently there is no need for action in this regard.

Individual subfields of synthetic cell research, for example research on bacterial cell division systems, take place in vitro, that is outside of living systems, and are not encompassed by the GenTG. These studies to date include no recognizable specific hazard potential; these systems involve no organisms capable of life.

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